HealthyNCT02898818
Vaginal and Oral Microbiome Crosstalk
An observational study of Healthy and Vaginal Discharge, run by Turku University Hospital at 1 site in Finland.
Trial summary
To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Vaginal Discharge
- What is being tested?
- vaginal and oral swab sample, questionnaire and papa smear
- Type of treatment
- Pill or oral medicine
- How many people
- 520 participants
- Where
- 1 siteFinland
- Study dates
- 19 Apr 2017to Sep 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients coming to Turku University Hospital Dermato-Venereology Department for venereal disease tests with or without vaginal discharge. Patients coming to Turku University Hospital Gynaecology Department by remission because of atypical papa smear test result or (controls) for some other reason. Patients coming to family planning clinics in The wellbeing services county of Southwest Finland.
Who may be able to join
- patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments or to family planning clinics in The wellbeing services county of Southwest Finland for previously mentioned reasons
Who cannot join
- those not meeting the criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, Turku, 20540
Niina K Hieta, MD, PhD, 2-3131620 ext. +358-, niina.hieta@tyks.fi
Katja M Kero, MD, PhD, 2-3130000 ext. +358-, katja.kero@tyks.fi
About this study
Official title: EMMI - Emättimen Mikrobiomi - Emättimen ja Suun Limakalvojen Vuorovaikutus
To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.
Read the detailed description
To study the vaginal and oral microbiome by swab samples and on selected groups, by papa smear test, to find out the constitution of normal and vaginal microbiome and the cross-talk between oral and vaginal mucosa. To find out about the impact of human papilloma virus on the microbiome and vice versa.
- Conditions
- Healthy, Vaginal Discharge
- Being tested
- vaginal and oral swab sample, questionnaire, papa smear
- Medical subject headings
- Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal and oral swab sample, questionnaireOther
vaginal and oral swab sample and questionnaire
papa smearOther
Papnicolaou Papa Smear test
| Study group | Role | What they receive |
|---|---|---|
| symptomless | vaginal and oral swab sample, questionnaire Receives: Other: vaginal and oral swab sample, questionnaire | |
| vaginal discharge | vaginal and oral swab sample, questionnaire Receives: Other: vaginal and oral swab sample, questionnaire | |
| atypical papa smear | vaginal and oral swab sample, questionnaire, papa smear Receives: Other: vaginal and oral swab sample, questionnaire; Other: papa smear | |
| no atypical papa smear | vaginal and oral swab sample, questionnaire, papa smear Receives: Other: vaginal and oral swab sample, questionnaire; Other: papa smear | |
| lichen planus | vaginal and oral swab sample, questionnaire, papa smear Receives: Other: vaginal and oral swab sample, questionnaire; Other: papa smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiome, papa smear
Differences in microbiome and papa smear
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start19 Apr 2017
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 520 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Niina K Hieta, MD, PhD, Principal investigator, specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898818
- Sponsor's protocol ID
- T146/2016
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2016
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMMI - Emättimen Mikrobiomi - Emättimen ja Suun Limakalvojen Vuorovaikutus
- ClinicalTrials.gov ID
- NCT02898818
- Acronym / sponsor ID
- T146/2016
- Conditions
- Healthy, Vaginal Discharge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Oulu University Hospital
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.
Detailed description
To study the vaginal and oral microbiome by swab samples and on selected groups, by papa smear test, to find out the constitution of normal and vaginal microbiome and the cross-talk between oral and vaginal mucosa. To find out about the impact of human papilloma virus on the microbiome and vice versa.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| symptomless | – | Other: vaginal and oral swab sample, questionnairevaginal and oral swab sample, questionnaire |
| vaginal discharge | – | Other: vaginal and oral swab sample, questionnairevaginal and oral swab sample, questionnaire |
| atypical papa smear | – | Other: vaginal and oral swab sample, questionnaire, Other: papa smearvaginal and oral swab sample, questionnaire, papa smear |
| no atypical papa smear | – | Other: vaginal and oral swab sample, questionnaire, Other: papa smearvaginal and oral swab sample, questionnaire, papa smear |
| lichen planus | – | Other: vaginal and oral swab sample, questionnaire, Other: papa smearvaginal and oral swab sample, questionnaire, papa smear |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming to Turku University Hospital Dermato-Venereology Department for venereal disease tests with or without vaginal discharge. Patients coming to Turku University Hospital Gynaecology Department by remission because of atypical papa smear test result or (controls) for some other reason. Patients coming to family planning clinics in The wellbeing services county of Southwest Finland.
Key inclusion criteria (1 listed)
- patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments or to family planning clinics in The wellbeing services county of Southwest Finland for previously mentioned reasons
Key exclusion criteria (1 listed)
- those not meeting the criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal and oral swab sample, questionnairevaginal and oral swab sample and questionnaire | Other | atypical papa smear, lichen planus, no atypical papa smear, symptomless, vaginal discharge |
| papa smearPapnicolaou Papa Smear test | Other | atypical papa smear, lichen planus, no atypical papa smear |
Primary outcome
microbiome, papa smear
Time frame: 5 years
Differences in microbiome and papa smear
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niina K Hieta, MD, PhD principal investigator
specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Vaginal Discharge, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niina K Hieta, MD, PhD (2-3131620 ext. +358-, niina.hieta@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiome, papa smear (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.